Evaluation of the Effectiveness of Auricular Acupuncture in Improving Dry Eye Symptoms in University Students

NCT06876077 | Completed

• 1 other identifier: 2468/DHYD-HDDD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Dry eye symptoms can cause various discomforts in the eyes and/or visual disturbances. This condition not only limits daily personal activities and reduces quality of life and mental health but also has negative economic impacts on families and society. Currently, complementary and alternative methods have been employed, with acupuncture being a promising treatment for patients with dry eye disease. Among these, auricular acupuncture has been proven effective in managing eye diseases and improving dry eye symptoms.

Conditions

Dry Eye Symptoms

Keywords

Auricular Acupuncture; Dry eye symptoms; University students

Outcome Measures

Primary Outcomes (1)

• Comparison of OSDI between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group

  The Ocular Surface Disease Index (OSDI) OSDI is a 12-item questionnaire that assesses dry eye symptoms occurring during the last week. The questions are divided into three sections which examine, respectively: subjective ocular symptoms, limitations in performing daily activities due to eye problems, and the influence of environmental conditions on eye comfort. Responses to every question ranged from 0, which represents "none of the time", to 4, which represents "all of the time". The final score ranges from 0 to 100 (sum of the 12 questions multiplied by 25 and divided by 12, and then rounded to the next integer) with higher scores representing greater disability: normal (0-12), mild (13-22), moderate (23-32), severe (33-100). A subject is classified as symptomatic when the total OSDI score is equal to or over thirteen points.

  Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26

Secondary Outcomes (2)

• Comparison of DEQ-5 between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group

  Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26

• Comparison of NEI VFQ-25 between auricular acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops and Sham acupuncture at TF4, TG2b, AT1b, CO12 and CO10 points combined with artificial tear drops group

  Baseline, Day 1, Day 6, Day 11, Day 16, Day 21 and Day 26

Other Outcomes (1)

• Adverse effects during auricular acupuncture

  During procedure

Study Arms (2)

Auricular acupuncture + Artificial Tears

EXPERIMENTAL

Auricular acupuncture is administered in each side of the ear for four weeks, with five sessions lasting five days each. Artificial tears were continuously administered over the four-week intervention period.

Other: Auricular acupuncture; Other: Artificial Tears (AT)

Sham auricular acupuncture + Artificial Tears

SHAM COMPARATOR

Sham auricular acupuncture is administered in each side of the ear for four weeks, with five sessions lasting five days each. The artificial tear is continuously administered over the four-week intervention period.

Other: Sham auricular acupuncture; Other: Artificial Tears (AT)

Interventions

Auricular acupuncture OTHER

Auricular acupuncture is administered in each side of the ear for 4 weeks using patches, each possessing a square shape with a side length of 10 mm, coupled with a sterilized needle measuring 0.25 x 1.3 mm. Five acupoints are selected on one ear, including the will be performed at Shenmen (TF4), Mu 1 (TG2b), Mu 2 (AT1b), Kidney (CO10), and Liver (CO12). These acupoints are believed to be effective in relieving dry eye symptoms. The patch will be kept on the auricle for 5 days and be replaced 5 times during the experimental period.

Auricular acupuncture + Artificial Tears

Sham auricular acupuncture OTHER

Sham auricular acupuncture is administered in each side of the ear for 4 weeks using patches, each possessing a square shape with a side length of 10 mm, without a needle. Five acupoints are selected on one ear, including the will be performed at Shenmen (TF4), Mu 1 (TG2b), Mu 2 (AT1b), Kidney (CO10), and Liver (CO12). These acupoints are believed to be effective in relieving dry eye symptoms. The patch will be kept on the auricle for 5 days and be replaced 5 times during the experimental period.

Sham auricular acupuncture + Artificial Tears

Artificial Tears (AT) OTHER

Artificial tear drops were applied 5-6 times per day over the 4-week period

Auricular acupuncture + Artificial Tears; Sham auricular acupuncture + Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet the following criteria:
• Be at least 18 years of age.
• Exhibit symptoms of dry eye, such as dryness, eye fatigue, eye itching, a foreign body sensation in the eye, burning or stinging sensations, blurry vision, light sensitivity, excessive tearing, or drooping eyelids.
• Have no refractive errors or related eye conditions.
• Visual acuity of both eyes ≥ 8/10 on the Snellen chart (normal vision).
• Show signs of dry eye with an OSDI score of ≥ 13 points
• Have never undergone auricular acupuncture before.
• Voluntarily agree to participate in the study.

You may not qualify if:

• Participants must meet at least one of the following criteria:
• Have symptoms suggesting an acute infection or conditions affecting the conjunctiva, sclera, eyelids, cornea, or systemic diseases.
• Are using other methods to treat eye diseases.
• Have undergone eye-related surgery within the past 3 months.
• Have changed or worn contact lenses during the study period.
• Have inflamed or ulcerated skin in both ears.
• Are debilitated, exhausted, or have severe concomitant diseases.
• Are using medications affecting vision (diuretics, antihistamines, antihypertensives) or eye drops.
• Have a history of acupuncture vertigo.
• Are contraindicated with Sodium Hyaluronate.
• Are participating in other interventional studies.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

University of Medical Center HCMC - Branch no.3

Ho Chi Minh City, Ho Chi Minh, 700000, Vietnam

Location

Related Publications (6)

• Wrobel-Dudzinska D, Osial N, Stepien PW, Gorecka A, Zarnowski T. Prevalence of Dry Eye Symptoms and Associated Risk Factors among University Students in Poland. Int J Environ Res Public Health. 2023 Jan 11;20(2):1313. doi: 10.3390/ijerph20021313.

  PMID: 36674068 BACKGROUND

• Hou PW, Hsu HC, Lin YW, Tang NY, Cheng CY, Hsieh CL. The History, Mechanism, and Clinical Application of Auricular Therapy in Traditional Chinese Medicine. Evid Based Complement Alternat Med. 2015;2015:495684. doi: 10.1155/2015/495684. Epub 2015 Dec 28.

  PMID: 26823672 BACKGROUND

• Tan JY, Molassiotis A, Wang T, Suen LK. Adverse events of auricular therapy: a systematic review. Evid Based Complement Alternat Med. 2014;2014:506758. doi: 10.1155/2014/506758. Epub 2014 Nov 10.

  PMID: 25435890 BACKGROUND

• Zhang CS, Yang AW, Zhang AL, May BH, Xue CC. Sham control methods used in ear-acupuncture/ear-acupressure randomized controlled trials: a systematic review. J Altern Complement Med. 2014 Mar;20(3):147-61. doi: 10.1089/acm.2013.0238. Epub 2013 Oct 19.

  PMID: 24138333 BACKGROUND

• Huang Q, Zhan M, Hu Z. Auricular Acupressure for Dry Eye Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Medicina (Kaunas). 2023 Jan 16;59(1):177. doi: 10.3390/medicina59010177.

  PMID: 36676806 BACKGROUND

• Asiedu K, Kyei S, Boampong F, Ocansey S. Symptomatic Dry Eye and Its Associated Factors: A Study of University Undergraduate Students in Ghana. Eye Contact Lens. 2017 Jul;43(4):262-266. doi: 10.1097/ICL.0000000000000256.

  PMID: 26963438 BACKGROUND

Related Links

• The Effects of Auriculotherapy on Relieving Symptoms of Dry Eye Syndrome

MeSH Terms

Interventions

Acupuncture, Ear; Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Philosophy

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 14, 2025
• Study Start: March 15, 2025
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

VN (1)